Cleared Abbreviated

K022510 - FONIX, MODEL 7000

K022510 is an FDA 510(k) clearance for FONIX, manufactured by Frye Electronics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Abbreviated 510(k) pathway after a 28-day FDA review.

K022510 · Frye Electronics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
28d
Days
Class 2
Risk

K022510 is an FDA 510(k) clearance for the FONIX, MODEL 7000. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Frye Electronics, Inc. (Tigard, US). The FDA issued a Cleared decision on August 27, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - the FDA ear, nose and throat device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Frye Electronics, Inc. devices

FDA 510(k) Submission Details - K022510

510(k) Number K022510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2002
Decision Date August 27, 2002
Days to Decision 28 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 90d · This submission: 28d
Pathway characteristics
Standards-based clearance path.

ETW Device Classification - Class 2, Special Controls

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 20
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K022510.
PRIMUS HEARING INSTRUMENT TEST UNIT
K113831 · Auditdata A/S · Apr 2012
GN OTOMETRICS TYPE 1053 FREEFIT
K110286 · Gn Otometrics A/S · Apr 2011
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · Siemens Hearing Instruments, Inc. · Jun 2007
FONIX FP35 HEARING AID ANALYZER
K980377 · Frye Electronics, Inc. · Mar 1998
GSI SA60 DPOAE SYSTEM
K970324 · Grason-Stadler, Inc. · Jun 1997
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
K960229 · Resound Corp. · Mar 1996